MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM12X60MM; KNEE STEMS

Model Number 1513-12-060

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Compass case report (b)(4): this patient has a left total attune knee done by surgeon.It is unknown when the knee was done.On xray, the femur has osteolysis and the tibia looks loose and has fallen into varus.The surgeon revised these components, and it turns out the femur and tibial tray were well fixed and difficult to remove.The patella was well fixed and retained.New implants were inserted.The tibia was prepped for an attune revision tray.The stem was overreamed by 1mm, the broach was fully seated.The real implant did not sit fully.It sat up 2mm.This seems to be a common event when using the attune revision system.All the trials sat perfectly, and the real implant would not seat fully.The pressfit is too much.No delay in surgery.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the revision was due to malalignment.The patient had pain.The tray sitting up required the use of a thinner insert.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a review of the device manufacturing records (dhr) was performed as part of this investigation.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude, that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATUNE PRESSFIT STR STEM12X60MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12422768
• MDR Text Key: 271502501
• Report Number: 1818910-2021-19323
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043546
• UDI-Public: 10603295043546
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1513-12-060
• Device Catalogue Number: 151312060
• Device Lot Number: J81N00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 10/27/2021
• Supplement Dates FDA Received: 09/27/2021; 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5 LEFT PS ATTUNE FEMUR; 5X12MM ATTUNE PS RP INSERT; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; UNK ATTUNE KNEE PATELLA; UNK KNEE TIBIAL TRAY ATTUNE RP